Rabies Pre-exposure Prophylaxis
Conditions
Brief summary
To determine optimum dose level for a single visit multidose intradermal injection of rabies vaccine with the aim to induce immunological memory in all subjects.
Interventions
BIOLOGICALrabies vaccine
Compare ID administration to IM administration. 1 visit schedule.
Sponsors
Leiden University Medical Center
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 50 Years
Healthy volunteers
Yes
Inclusion criteria
* Age ≥ 18 years * Good health according to the investigator * Willingness and ability to adhere to the study regimen * Able to give informed consent
Exclusion criteria
* Known or suspected previous vaccination against rabies * Known or suspected allergy against any of the vaccine components * History of unusual or severe reactions to any previous vaccination * Immunocompromized state due to illness or medication * Administration of plasma or blood products three months prior to inclusion in the study * (hydroxy)chloroquine or mefloquine use * History of any neurological disorder including epilepsy or febrile seizures * Pregnancy or breastfeeding * Any current infectious disease other than seasonal cold * Bleeding disorders or use of anticoagulants
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Memory response in vaccinated subjects 1 year after primary vaccination (defined as seroprotection rate for all subjects within 7 days post-booster in a simulated post-exposure scenario) | 1 year |
Countries
Netherlands
Contacts
Primary ContactEmile Jonker, MD
Outcome results
None listed